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Internet-based Videoconferencing to Address Alcohol Use and Pain

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ClinicalTrials.gov Identifier: NCT03982433
Recruitment Status : Completed
First Posted : June 11, 2019
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Boston University Charles River Campus

Brief Summary:
This research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.

Condition or disease Intervention/treatment Phase
Chronic Pain Alcohol Use, Unspecified Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain Not Applicable

Detailed Description:
This study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with HIV and determine its feasibility and acceptability. Through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with HIV/AIDS (PLWHA) through videoconferencing. Intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants all undergo assessment and intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : June 27, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: Intervention
participants all receive the intervention
Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain
Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference




Primary Outcome Measures :
  1. Brief Pain Inventory Pain Severity [ Time Frame: past 7 days ]

    BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst.

    Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10


  2. Brief Pain Inventory Pain Interference [ Time Frame: past 7 days ]

    BPI consists of 11-point scale items that reflect pain severity and pain interference

    Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10


  3. Alcohol Time Line Follow Back...Heavy Drinking Episodes [ Time Frame: past 30 days ]
    number of heavy drinking episodes in the past 30 days

  4. Alcohol Time Line Follow Back...Average Drinks Per Week [ Time Frame: past 30 days ]
    average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)

  5. Client Satisfaction Questionnaire-8 [Modified] [ Time Frame: past 30 days ]

    Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment.

    The possible range of scores is 8-32.


  6. Perceptions of Treatment Questionnaire [ Time Frame: past 30 days ]
    Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.


Secondary Outcome Measures :
  1. Goal Systems Assessment Battery-Pain [ Time Frame: past 30 days ]
    Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.

  2. Goal Systems Assessment Battery-Alcohol [ Time Frame: past 30 days ]
    Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • engaged in HIV care, heavy drinking by more than 7/14 drinks per week (women/men) or by single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the Brief Pain Inventory (BPI) non-cancer related pain.

Exclusion Criteria:

  • psychoactive medication for pain or alcohol use for few than 2 months
  • history of bipolar disorder, schizophrenia, other psychotic disorder
  • current suicidal intent
  • prior history of alcohol withdrawal related seizures or delirium tremens
  • current behavioral treatment for pain or alcohol use
  • any scheduled surgery within next 6 months or acute life-threatening illness that requires treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982433


Locations
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United States, Massachusetts
General Clinical Research Unit, Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Tibor P Palfai, PhD Boston University
  Study Documents (Full-Text)

Documents provided by Boston University Charles River Campus:
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Responsible Party: Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03982433    
Other Study ID Numbers: 4546
UH2AA026192 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2019    Key Record Dates
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University Charles River Campus:
HIV
Additional relevant MeSH terms:
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Chronic Pain
Alcohol Drinking
Pain
Neurologic Manifestations
Drinking Behavior